Study on Proton or Photon Radiation Therapy for Retroperitoneal Sarcomas

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01659203

This clinical trial is exploring the safety and best dose of proton or photon radiation therapy for treating retroperitoneal sarcomas, which are tumors located at the back of the abdomen. The study aims to find out if these radiation methods can effectively target tumors while minimizing damage to healthy tissue.

Patient Parameters

Program Overview

This study is testing the safety and effectiveness of two types of radiation therapy—proton beam and IMRT (Intensity-Modulated Radiation Therapy)—for treating retroperitoneal sarcomas, which are soft tissue tumors located deep in the abdomen. The goal is to determine the highest safe dose of radiation that can be given before surgery to remove the tumor. Proton radiation is thought to be more precise, potentially reducing side effects compared to traditional radiation. Participants will receive radiation therapy before surgery, with a focus on delivering a higher dose to areas of the tumor that are considered higher risk.

Description

Before joining the study, you may be asked to provide additional blood samples for research purposes. The study aims to find the highest safe dose of radiation therapy for retroperitoneal sarcomas, so not all participants will receive the same dose. Your dose will depend on how previous participants have responded to their treatment. Your doctor will inform you about the dose you will receive.

Radiation planning is a standard procedure for all patients receiving radiation therapy. Before starting treatment, you will have a CT scan to help doctors plan your radiation therapy. This scan is in addition to any scans done to check if you can join the study.

You will receive radiation therapy every weekday for about six weeks as an outpatient. During this time, you will have weekly check-ups with the study doctor to monitor your health and any side effects. Each visit will last about 15 minutes.

After finishing radiation therapy, you will be checked for side effects before your surgery. This includes a chest CT scan, abdominal/pelvic CT or MRI, and routine blood tests.

You will have follow-up visits one month and four months after surgery to check your health and any side effects. These visits will include medical history reviews, vital signs, weight checks, and routine blood tests. After the four-month visit, you will have check-ups twice a year for the first five years, then once a year for life.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with primary soft tissue sarcoma in the retroperitoneum
  • Tumor that can be measured
  • Expected to live more than 2 years

Exclusion Criteria

  • Previous radiation therapy for retroperitoneal sarcoma
  • Pregnant or breastfeeding
  • Chemotherapy within 4 weeks before joining the study
  • Taking other experimental treatments
  • Other types of sarcomas
  • Multiple tumors, or cancer that has spread to lymph nodes or other parts of the body
  • History of sensitivity to radiation therapy
  • Uncontrolled illness
  • History of another invasive cancer within the past 3 years
  • HIV positive and on combination anti-retroviral therapy

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